AKTEN
These highlights do not include all the information needed to use AKTEN safely and effectively. See full prescribing information for Akten . AKTEN (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use. Initial U.S. Approval: 1972
Approved
Approval ID
70ff9fb7-d323-4fe6-b1b1-6033e05f0749
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 5, 2023
Manufacturers
FDA
Thea Pharma Inc.
DUNS: 117787029
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82584-792
Application NumberNDA022221
Product Classification
M
Marketing Category
C73594
G
Generic Name
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 5, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LIDOCAINE HYDROCHLORIDE ANHYDROUSActive
Quantity: 35 mg in 1 mL
Code: EC2CNF7XFP
Classification: ACTIB